Catalyst overview
Research summary
This catalyst tracks a Approved quarterly sales for PYRUKYND (Mitapivat) in Beta thalessemia. The expected timing is based on the latest available company guidance and may change.
ENERGIZE, ENERGIZE-T studies. 6/3/24- ENERGIZE-T 48-wk study topline data, met primary & secondary endpoint. 12/8/24- Filed sNDA. 9/4/25- PDUFA goal date extended from September 7, 2025 to December 7, 2025. Presentations at ASH'25. 10/30/25:- FDA REMS-related PDUFA extension confirmed; CHMP positive, EC decision expected early 2026; Saudi approval and UAE review ongoing. 12/08/25:- FDA did not decide by Dec 7 PDUFA date. sNDA under active review, decision timing unknown. 12/23/25:- FDA approved AQVESME (mitapivat) for adult alpha/beta thalassemia; U.S. launch expected late January 2026. 02/12/26:- AQVESME now available in US following REMS implementation; launch underway. 04/29/26:- UAE approved PYRUKYND for thalassemia; EC review ongoing; Q1 2026 thal revenue $20.7M, 242 U.S. prescriptions. 05/12/26:- ENERGIZE Ph3 OLE shows hemoglobin durability to 127 weeks; new subgroup data presented at EHA 2026. 07/30/26:- Q2 mitapivat net revenue was $44.7M; EC approved thalassemia use; 442 AQVESME prescriptions.
Verification
Confirm timing and program details against the company announcement or filing.